FDA-Device2014-07-02Class II

IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

Intuitive Surgical, Inc.
Hazard

In some procedures when using the endoscope in conjunction with the IS4000 (da Vinci Xi) System, the surgical view has an orange-yellow tint which can make it hard to differentiate between tissue

Sold states
Distributed in the states of FL, TX, and NY.
Affected count
19 units
Manufactured in
1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, United States
Products
IS4000 da Vinci Xi - Endoscope accessory; 0 Degree, 8mm Endoscope. Intuitive Surgical Inc.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1871-2014

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